risedronate sodium
Pharmaranks rates Risedronate Sodium 2.8/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Risedronate Sodium is a bisphosphonate used to treat Extramammary Paget Disease, Postmenopausal Osteoporosis.
Bisphosphonate · by Teva
Generic of Actonel
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Risedronate Sodium
- Drug class
- Bisphosphonate
- Form
- Tablet, delayed release
- Strength
- Risedronate Sodium 150MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Teva
- Half-life
- about 561 hours — roughly 23 days (how long it stays in your system)
- What the pharmacy pays
- ~$73.02 for 30 — not your price
- FDA application
- ANDA079215
What is Risedronate Sodium?
From the FDA label:Risedronate sodium delayed-release tablets contain a pH-sensitive enteric coating and a chelating agent (EDTA). Risedronate is a pyridinyl bisphosphonate that inhibits osteoclast-mediated bone resorption and modulates bone metabolism. Each risedronate sodium delayed-release tablet for oral administration contains the equivalent of 35 mg of risedronate sodium (amorphous). The molecular formula for risedronate sodium (amorphous) is C 7 H 10 NNaO 7 P 2. The chemical name of risedronate sodium is [1-hydroxy-2-(3-pyridinyl)ethylidene]bis[phosphonic acid] sodium salt. The chemical structure of risedronate sodium (amorphous) is the following: Molecular Weight: 305.09 Risedronate sodium is a white to off-white, amorphous powder. It is soluble in water, practically insoluble in methanol and dichloromethane. Inactive Ingredients Colloidal silicon dioxide, edetate disodium, ferric oxide yellow, hypromellose, lactose monohydrate, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, sodium starch glycolate, sodium stearyl fumarate, talc, and triethyl citrate. The imprinting ink contains ferric oxide black, propylene glycol, and shellac glaze. structure 01
How to use
One 35 mg delayed-release tablet once-a-week (2.1) Instruct patients to: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast with at least 4 ounces of plain water (2.2) • Avoid lying down for 30 minutes after taking risedronate sodium delayed-release tablets (2.2) • Take supplemental calcium and vitamin D if dietary intake is inadequate (2.3) 2.1 Treatment of Postmenopausal Osteoporosis [ see Indications and Usage (1.1) ] The recommended regimen is: • one 35 mg delayed-release tablet orally, taken once-a-week [see Indications and Usage (1.1)] 2.2 Important Administration Instructions Instruct patients to do the following: • Take risedronate sodium delayed-release tablets in the morning immediately following breakfast. Risedronate sodium delayed-release tablets should be taken immediately following breakfast and not under fasting conditions because of a higher risk of abdominal pain if taken before breakfast when fasting. • Swallow risedronate sodium delayed-release tablets whole while in an upright position and with at least 4 ounces of plain water to facilitate delivery to the stomach. Avoid lying down for 30 minutes after taking the medication [ see Warnings and Precautions (5.2) ]. • Do not chew, cut, or crush risedronate sodium delayed-release tablets. 2.3 Recommendations for Calcium and Vitamin D Supplementation Instruct…
Side effects
Most common adverse reactions (greater than 5%) include: diarrhea, influenza, arthralgia, back pain, and abdominal pain (6.1) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis, uveitis) have been reported rarely (6.2) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Treatment of Postmenopausal Osteoporosis Once-a-Week Dosing with Risedronate Sodium Delayed-Release tablets The safety of risedronate sodium delayed-release 35 mg once-a-week in the treatment of postmenopausal osteoporosis was assessed in a 1-year, double-blind, multicenter study comparing risedronate sodium delayed-release 35 mg once-a-week to risedronate sodium immediate-release 5 mg daily in postmenopausal women 50 years of age or older. Risedronate sodium delayed-release was administered either at least 30 minutes before (N = 308) or immediately following (N = 307) breakfast, and risedronate sodium…
Warnings
Important safety information
Products Containing Same Active Ingredient : Patients receiving Actonel should not be treated with risedronate sodium delayed-release tablets (5.1) • Upper Gastrointestinal Adverse Reactions can occur. Instruct patients to follow dosing instructions. Discontinue use if new or worsening symptoms occur (5.2) • Hypocalcemia may worsen and must be corrected prior to use (5.3) • Osteonecrosis of the Jaw has been reported (5.4) • Severe Bone, Joint, Muscle Pain may occur. Discontinue use if severe symptoms develop (5.5, 6.2) • Atypical Femur Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture (5.6) 5.1 Drug Products with the Same Active Ingredient Risedronate sodium delayed-release tablets contain the same active ingredient found in Actonel ® . A patient being treated with Actonel should not receive risedronate sodium delayed-release tablets. 5.2 Upper Gastrointestinal Adverse Reactions Risedronate sodium, like other bisphosphonates administered orally, may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when risedronate sodium is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers) [ see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17) ]. Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding and rarely followed by esophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. In some cases, these have been severe and required hospitalization. Physicians should therefore be alert to any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue risedronate sodium and seek medical attention if they develop dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended 4 ounces of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. Therefore, it is very important that the full dosing instructions are provided to, and understood by, the patient [ see Dosage and Administration (2) ]. In patients who cannot comply with dosing instructions due to mental disability, therapy with risedronate sodium should be used under appropriate supervision. There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials. 5.3 Mineral Metabolism Hypocalcemia has been reported in patients taking risedronate sodium delayed-release tablets. Treat hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting risedronate sodium therapy. Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. Adequate intake of calcium and vitamin D is important in all patients [ see Contraindications (4), Adverse Reactions (6.1), Information for Patients (17) ]. 5.4 Jaw Osteonecrosis Osteonecrosis of the jaw (ONJ), which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in patients taking bisphosphonates, including risedronate. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (for example, tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (for example, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (for example, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates. For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit/risk assessment. Patients who develop ONJ while on bisphosphonate therapy should receive care by an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of bisphosphonate therapy should be considered based on individual benefit/risk assessment [ see Adverse Reactions (6.2) ]. 5.5 Musculoskeletal Pain In postmarketing experience, there have been reports of severe and occasionally incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates [ see Adverse Reactions (6.2) ]. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping medication. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Consider discontinuing use if severe symptoms develop. 5.6 Atypical Subtrochanteric and Diaphyseal Femoral Fractures Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are traverse or short oblique in orientation without evidence of comminution. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (for example, prednisone) at the time of fracture. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered, pending a risk/benefit assessment, on an individual basis. 5.7 Renal Impairment Risedronate sodium is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/min) because of lack of clinical experience. 5.8 Laboratory Test Interactions Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with risedronate sodium have not been performed.
Who should not take Risedronate Sodium
Risedronate sodium delayed-release tablets contraindicated in patients with the following conditions: 1. Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia [ see Warnings and Precautions (5.2) ] 2. Inability to stand or sit upright for at least 30 minutes [ see Dosage and Administration (2), Warnings and Precautions (5.2) ] 3. Hypocalcemia [ see Warnings and Precautions (5.3) ] 4. Known hypersensitivity to any component of this product. Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported [ see Adverse Reactions (6.2) ] • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia (4, 5.2) • Inability to stand or sit upright for at least 30 minutes (4, 5.2) • Hypocalcemia (4, 5.3) • Known hypersensitivity to any component of this product (4, 6.2)
Overdose — what happens if you take too much
Decreases in serum calcium and phosphorus following substantial overdose may be expected in some patients. Signs and symptoms of hypocalcemia may also occur in some of these patients. While milk or antacids containing calcium may be given to bind risedronate sodium immediate-release and reduce absorption of the drug, the impact of this intervention for risedronate sodium delayed-release tablets has not been evaluated. In cases of substantial overdose, gastric lavage may be considered to remove unabsorbed drug. Standard procedures that are effective for treating hypocalcemia, including the administration of calcium intravenously, would be expected to restore physiologic amounts of ionized calcium and to relieve signs and symptoms of hypocalcemia. Lethality after single oral doses of risedronate was seen in female rats at 903 mg/kg and male rats at 1703 mg/kg. The minimum lethal dose in mice and rabbits was 4000 mg/kg and 1000 mg/kg, respectively. These values represent 320 to 620 times the human Paget’s disease dose of 30 mg/day based on surface area (mg/m 2 ).
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Risedronate is not metabolized and does not induce or inhibit hepatic microsomal drug-metabolizing enzymes (for example, Cytochrome P450). Calcium supplements, antacids, proton pump inhibitors (PPIs), H 2 blockers, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of risedronate sodium (7.1, 7.2) 7.1 Calcium Supplements/Antacids When risedronate sodium was administered following breakfast, the co-administration of a tablet containing 600 mg of elemental calcium and 400 international units vitamin D reduced risedronate bioavailability by approximately 38% [ see Clinical Pharmacology (12.3) ]. Calcium supplements, antacids, magnesium-based supplements or laxatives, and iron preparations interfere with the absorption of risedronate sodium and should not be taken together. 7.2 Histamine 2 (H 2 ) Blockers and Proton Pump Inhibitors (PPIs) Drugs that raise stomach pH (for example, PPIs or H 2 blockers) may cause faster drug release from enteric coated (delayed-release) drug products such as risedronate sodium. Co-administration of risedronate sodium with the PPI, esomeprazole, increased risedronate bioavailability. The maximum plasma concentration (C max ) and the area under the plasma concentration (AUC) were increased by 60 percent and 22 percent, respectively. Concomitant administration of risedronate sodium and H 2 blockers or PPIs is not recommended. 7.3 Hormone Therapy Concomitant use of risedronate sodium with estrogens and estrogen agonist/antagonists has not been studied. 7.4 Aspirin/Nonsteroidal Anti-Inflammatory Drugs In the Phase 3 study comparing risedronate sodium 35 mg once-a-week immediately following breakfast and risedronate sodium 5 mg daily, 18% of NSAID users (any use) in both groups developed upper gastrointestinal adverse reactions. Among non-users, 13% of patients taking risedronate sodium 35 mg once-a-week immediately following breakfast developed upper gastrointestinal adverse reactions, compared to 12% taking risedronate sodium 5 mg daily.
How long does Risedronate Sodium stay in your body?
The elimination half-life of risedronate sodium is about 561 hours — roughly 23 days — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) exponential half-life, the only half-life the label reports, measured in osteopenic postmenopausal women. It is very long because risedronate is slowly released back out of bone, where about 60% of an absorbed dose goes — it does not mean the drug stays in the blood for weeks; the label notes roughly half of the absorbed dose is excreted in the urine within 24 hours. There is no active metabolite and this is not a prodrug: the label states there is no evidence of systemic metabolism, and the drug is excreted unchanged. Populations the label names: older adults (over 60) — bioavailability and disposition are similar to younger subjects, no dosage adjustment. Kidney impairment — risedronate is cleared unchanged by the kidney, and renal clearance falls about 70% at a creatinine clearance around 30 mL/min; the label does not recommend it below 30 mL/min, but no adjustment is needed at 30 mL/min or above. Liver impairment — not studied, but risedronate is not metabolized by the liver, so the label says an adjustment is unlikely to be needed.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: ACTONEL (risedronate sodium) tablets — FDA label, DailyMed.
Drug class
How this class works, per Bisphosphonate - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Risedronate Sodium ranks — best-rated bisphosphonate for:
Dosage forms
Tablet, delayed release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Risedronate Sodium treat?
- Risedronate Sodium (Risedronate Sodium) may be used to treat extramammary paget disease, postmenopausal osteoporosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Risedronate Sodium work?
- Risedronate Sodium is a bisphosphonate. Bisphosphonates stick to the mineral surface of bone, especially where it is being broken down. When the bone-dissolving cells (osteoclasts) take the drug up, it disables or kills them, slowing bone loss and helping keep bones denser and stronger.
- How is Risedronate Sodium rated?
- pharmaranks gives Risedronate Sodium a composite score of 2.8 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Risedronate Sodium cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $73.02 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Binosto — about $7.76 on the same basis.
- Is there a coupon or discount for Risedronate Sodium?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Risedronate Sodium. To pay less, Risedronate Sodium is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Risedronate Sodium?
- Risedronate Sodium is marketed by Teva. You can see Teva's full profile, rating, and other products on pharmaranks.
- Is Risedronate Sodium a brand-name or generic drug?
- Risedronate Sodium is a generic medication; its active ingredient is Risedronate Sodium. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Risedronate Sodium available over the counter?
- No. Risedronate Sodium is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Risedronate Sodium come in?
- Risedronate Sodium is currently marketed as tablet, delayed release, per the FDA's National Drug Code Directory.
- What class of drug is Risedronate Sodium?
- Risedronate Sodium is classified as bisphosphonate, per the FDA's Established Pharmacologic Class.
- Is Risedronate Sodium FDA-registered?
- Risedronate Sodium is on record with the U.S. FDA under application number ANDA079215. You can verify this on its official FDA label.
- Has Risedronate Sodium been recalled by the FDA?
- Risedronate Sodium has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Risedronate Sodium safe?
- There's no single safe-or-not verdict. pharmaranks gives Risedronate Sodium a recall-safety score of 56/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Risedronate Sodium?
- Risedronate Sodium's side effects are taken directly from its FDA label. From the label: Most common adverse reactions (greater than 5%) include: diarrhea, influenza, arthralgia, back pain, and abdominal pain (6.1) Hypersensitivity reactions (angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis), and eye inflammation (iritis,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
aredia
Pamidronate Disodium
zometa
Zoledronic Acid
reclast
Zoledronic Acid
actonel
Risedronate Sodium
atelvia
Risedronate Sodium
binosto
Alendronate Sodium
Compare Risedronate Sodium head-to-head
More bisphosphonate drugs
Guides for this medication
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
risedronate sodium
56/100